|
Device | ACUITY SPIRAL LEAD FAMILY |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S260 |
Date Received | 11/26/2010 |
Decision Date | 08/05/2011 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES: 1) ADD AN ALTERNATE DEXAMETHASONE ACETATE SUPPLIER; 2) UPDATE TO DXA MIXING PROCESS PARAMETERS TO ENHANCE PROCESS CAPABILITY; 3) ALTERNATE ANALYTICAL METHOD TO TEST FOR DOSAGE AND PRODUCT DEGRADATION; 4) MODIFICATION OF THE ANALYTICAL METHODS TO REMOVE IMPURITY PEAKS OBSERVED; AND 5) ADD IN PROCESS VERIFICATION FOR MIX HOMOGENEITY. |